A Columbia pharmaceutical manufacturer is ramping up production of a critically needed drug in response to a national shortage.
Ritedose has launched emergency production of a rare albuterol dosage needed for pediatric asthma patients, in response to demand from hospitals around the country that were having trouble getting children the medicine they need.
The drug has been in short supply since last year as the handful of manufacturers who produce albuterol have faced production issues.
One albuterol producer, Akorn Operating Company, declared bankruptcy in 2020 and ended all production when it went out of business in February, CNN reports. That same month, the only other albuterol producer in the country — Cayce-based Nephron Pharmaceuticals — put many of its employees on furlough. That left many health care providers scrambling to find new sources of the drug.
“We actually had patients, not hospitals, reaching out to us directly to ask, ‘Can you make this? We need this drug. My child needs this drug,’” said Ritedose president Jody Chastain.
Ritedose had made albuterol products for decades, but not the special nebulizer commonly used as an inhaled remedy for breathing issues in doctor’s offices and children’s hospitals. It’s a very specific, niche need — Chastain estimates it represents about 2% of the market for albuterol products — which is why so few companies specialize in producing it.
“From a straight financial perspective, you wouldn’t make it. There’s not enough of a market for it,” Chastain said. “But we want to do the right thing for the patients.”
Ritedose has started continuous production under an emergency need measure, shipping the needed drug across the country. The company will continue making albuterol throughout the shortage, Chastain said, but Ritedose is asking the Food and Drug Administration for approval to continue making the drug long-term.
Other drug makers have also stepped up to produce albuterol during the shortage, but Ritedose will be the only one producing the drug in a blow fill seal where other manufacturers are pre-filling the drug in a syringe. The automated seal allows a doctor to release the sterile liquid into an inhaler to be turned into a breathable mist.